Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Infection resolution rates within 5 days of treatment
研究概览
简要总结
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
详细描述
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis patients with ascites
- •Ascitic fluid PMN cell count >250/mm3
- •Age: 16~70 years old
排除标准
- •Allergic to 3rd generation cephalosporin or quinolone
- •Antibiotics within 2 weeks
- •Open abdominal surgery within 4 weeks
- •Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
- •HCC with portal vein thrombosis
- •Pregnant woman
- •HIV positive
研究组 & 干预措施
Cefotaxime
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
干预措施: Cefotaxime (Drug)
Ceftriaxone
iv 2G q 24hrs
干预措施: Ceftriaxone (Drug)
Ciprofloxacine
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Infection resolution rates within 5 days of treatment
时间窗: 5 days (120 hours)
PMN \< 250/mm3 from ascitic fluid
次要结局
- Mortality & recurrence rates within 1 month(1 month)